dicyclomine hydrochloride

Generic: dicyclomine hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dicyclomine hydrochloride
Generic Name dicyclomine hydrochloride
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dicyclomine hydrochloride 20 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-0795
Product ID 0591-0795_cdc9e5f4-36d9-40dc-894f-2d8682e4a61b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085223
Listing Expiration 2026-12-31
Marketing Start 1986-07-30

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05910795
Hyphenated Format 0591-0795

Supplemental Identifiers

RxCUI
991061 991086
UPC
0305910795016 0305910794019
UNII
CQ903KQA31

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dicyclomine hydrochloride (source: ndc)
Generic Name dicyclomine hydrochloride (source: ndc)
Application Number ANDA085223 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0591-0795-01)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (0591-0795-10)
source: ndc

Packages (2)

0591-0795-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-0795-01) 0591-0795-10 1000 TABLET in 1 BOTTLE, PLASTIC (0591-0795-10)

Ingredients (1)

dicyclomine hydrochloride (20 mg/1)

Linked Drug Pages (1)

Dicyclomine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cdc9e5f4-36d9-40dc-894f-2d8682e4a61b", "openfda": {"upc": ["0305910795016", "0305910794019"], "unii": ["CQ903KQA31"], "rxcui": ["991061", "991086"], "spl_set_id": ["a5937c7b-cdfc-46e6-a0fa-541b24f91d47"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0795-01)", "package_ndc": "0591-0795-01", "marketing_start_date": "19860730"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0591-0795-10)", "package_ndc": "0591-0795-10", "marketing_start_date": "19860730"}], "brand_name": "Dicyclomine Hydrochloride", "product_id": "0591-0795_cdc9e5f4-36d9-40dc-894f-2d8682e4a61b", "dosage_form": "TABLET", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "0591-0795", "generic_name": "Dicyclomine Hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dicyclomine Hydrochloride", "active_ingredients": [{"name": "DICYCLOMINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA085223", "marketing_category": "ANDA", "marketing_start_date": "19860730", "listing_expiration_date": "20261231"}